REG - IQ-AI Limited - Imaging Biometrics granted FDA “Fast-Track”

IQ-AIAnnouncement

19/12/2023 14:30

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RNS Number : 3492X  IQ-AI Limited  19 December 2023

IQ-AI Ltd

("IQ-AI" or the "Company")

 

Imaging Biometrics granted FDA "Fast-Track"

Dec 19, 2023 - Imaging Biometrics, LLC (IB), a wholly owned subsidiary of
IQ-AI Ltd (LSE: IQAI), is pleased to announce that the U.S. Food and Drug
Administration (FDA) has granted "Fast-Track" designation for oral gallium
maltolate (GaM), IB's therapeutic for the treatment of adult patients with
relapsed or refractory glioblastoma (GBM), IDH-wildtype.

 

The FDA's decision to grant Fast-Track status reflects the urgency and unmet
medical need associated with GBM. Receiving both Fast-Track and Orphan Drug
designations from the FDA for oral GaM validates the importance of advancing
the development of this treatment for these patients.

 

Fast-Track designation offers an accelerated review process with the FDA via
increased communication and collaboration during the development process. IB
is now well positioned to utilize this streamlined and efficient process to
bring this promising agent to the market as quickly as possible.

 

"We are very pleased to receive Fast Track designation," said Trevor Brown,
CEO of IQ-AI. "This is an important milestone as well as a commercial
accelerator, and we are firmly committed to working closely with the FDA to
expedite the clinical development of oral GaM."

 

--ENDS-

 

The Directors of the Company accept responsibility for the contents of this
announcement.

 

For further information, please contact:

 

 IQ-AI Ltd

 Trevor Brown/Vinod Kaushal/Brett Skelly/Michael Schmainda

 Tel: 020 7469 0930
 Peterhouse Capital Limited (Financial Adviser and Broker)

 Lucy Williams/Heena Karani

 Tel: 020 7220 9797

 

 

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